FDA device enforcement
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of IL.
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LeMaitre Vascular, Inc. recall records
10 reported ongoing
10 records in this archive. Latest source date Feb 10, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for Artegraft Vascular Graft; REF#: AG740;
FDA device enforcement
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
Class IIReported ongoing
Distribution: US distribution to the state of: AR
FDA device enforcement
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) A...
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
FDA device enforcement
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where...
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Class IIReported ongoing
Distribution: No US distribution. International distribution to Great Britian and Switzerland.
FDA device enforcement
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E16...
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class IIReported ongoing
Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ...
FDA device enforcement
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class IIReported ongoing
Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ...
FDA device enforcement
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class IIReported ongoing
Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, ...
FDA device enforcement
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
The guide tip can become damaged and result in the tip detaching.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
FDA device enforcement
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvuloto...
Burrs (molding flash) on the cutter may tear the harvested vien
Class IIReported ongoing
Distribution: International distribution to the countries of Belgium, France, Germany, and United Kingdom.
FDA device enforcement
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by th...
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking ...
Class IIReported ongoing
Distribution: No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Reasons in these listed records
- Labeling mix-up resulting in the incorrect lot outer packaging of product.
- The device was incorrectly packed in the wrong size labeled outer packaging.
- The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
- Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
These examples come from this result page and are not a ranking of every recall reason.
Checking LeMaitre Vascular, Inc.
Is there a recall on lemaitre vascular, inc. right now?
This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.